Pharmacologic class: Glucagon-like peptide-1 (GLP-1) receptor agonist.
Active ingredient(s): Liraglutide [rDNA origin] 6mg/mL; solution for SC injection.
Company: Novo Nordisk
Indication(s): Adjunct to reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial BMI of ≥30 kg/m2 (obese), or ≥27 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (eg, hypertension, T2DM, dyslipidemia). Limitations of use: not indicated for type 2 diabetes. Do not use with Victoza, other GLP-1 receptor agonists, or insulin. Effects on cardiovascular morbidity and mortality have not been established. Safety and efficacy with concomitant other weight loss products has not been established. Not studied in patients with history of pancreatitis.
Pharmacology: Liraglutide binds to and activates the GLP-1 receptor, a cell-surface receptor coupled to adenylyl cyclase activation through the stimulatory G-protein, Gs.
Clinical trials: The safety and efficacy of Saxenda for chronic weight management in conjunction with reduced caloric intake and increased physical activity were studied in three 56-week trials.
Study 1 (n=3731) and Study 3 (n=422) included patients who were obese or overweight and at least one weight-related comorbid condition (eg, dyslipidemia, hypertension). Study 2 (n=635) included patients with type 2 diabetes who were either overweight or obese.
For Study 1 and Study 2, the primary efficacy parameters were mean percent change in body weight and the percentages of patients achieving ≥5% and 10% weight loss from baseline to week 56. For Study 3, the primary efficacy parameters were mean percent change in body weight from randomization to week 56, the percentage of patients not gaining >0.5% body weight from randomization (eg, after run-in) to week 56, and the percentage of patients achieving ≥5% weight loss from randomization to week 56.
After 56 weeks, treatment with Saxenda resulted in a statistically significant reduction in weight compared with placebo. A greater proportion of patients treated with Saxenda achieved 5% and 10% weight loss than those treated with placebo. In Study 3, statistically significantly more patients randomized to Saxenda than placebo had not gained more than 0.5% of body weight from randomization to week 56.
For more clinical trials data, see full labeling.